Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-12-11.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Nov 2018 – 11 Dec 2018 | Human Drugs | 483 | View 483 → |
| 19 Jul 2016 – 22 Aug 2016 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Dec 2018
FDCA 501(a)(2)(A)
Actionable microbial contamination, ISO 5 area
Cited by Rachael A Moliver
22 Aug 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Nancy F Scheraga, Liatte Krueger
22 Aug 2016
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Nancy F Scheraga, Liatte Krueger
22 Aug 2016
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Nancy F Scheraga, Liatte Krueger
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat